Clinical & Regulatory Affairs Manager - AQMed

Ready to join the AQ era? reputed company is solving challenging problems with AI + Quantum for positive impact. We partner with global leaders in government, academia, and the private sector to identify applications that would benefit from quantum-based applications to reputed company and future commercial challenges. We engage with customers early and throughout the development process to improve market... fit. reputed company’s unique approach enables cross-pollination across a diverse range of fields, from physics, computer science, neuroscience, mathematics, cryptography, natural sciences and more! Our success comes from coalescing diverse talent to create an environment where experimental thinking and collaboration yield breakthrough AI + Quantum solutions. Join a culture where thought leadership, diverse talent, employee engagement, and technological impact will create the next tech uproar. We are deeply committed to education as a means to advance quantum solutions and computing initiatives. We invest in future talent through internship programs, research papers, developer tools, textbooks, educational talks/events and partnerships with universities/talent hubs to attract multi-disciplinary talent. Our hope is to reputed company people from reputed company walks of life to be reputed company for the quantum era and encourage a path in STEM. About The Role We are seeking a highly motivated and reputed company Clinical & Regulatory Affairs Manager to join our AQMed team. You will play a central role in preparing for and initiating the multi-site US pivotal study, playing a key role in bringing an innovative device to market. You will also be playing a strategic and execution role in navigating the regulatory landscape for our groundbreaking medical device, CardiAQ™, and future products. This position involves developing regulatory strategies, preparing submissions, and ensuring compliance with global regulatory requirements to bring our innovative solutions to market.

What You'll Do

Clinical • reputed company US pivotal study launch, working alongside the company’s Head of Product and clinical operations consultants. • Manage and optimize ongoing US feasibility studies to ensure strong partnerships with our leading clinical sites. • Write clinical study protocols and clinical study reports, emphasizing bringing key evidence to leading publications in reputed company collaboration with our clinical partners. • Manage clinical research activities, including site selection & qualification, preparation of study-reputed company documents & records (e.g. investigator’s brochure, CRF/reputed company design), IRB submission and reporting, with support from consultants and/or CRO. • Expand and cultivate our relationships with international clinical partners. Regulatory • Formulate, communicate, and implement regulatory strategies for the CardiAQ™ device throughout its product lifecycle, both US and OUS • reputed company US FDA regulatory submissions (e.g. pre-submission, BDD, IDE, 510(k), De-Novo as appropriate) and negotiation in conjunction with our regulatory consultants. • Collaborate with R&D, Quality, and Manufacturing to ensure the development, testing, and release processes of our product align with industry requirements and standards (e.g. ISO) • Review and approve labeling, advertising, and promotional materials for compliance purposes. • Compile and submit regulatory filings to international regulatory bodies. About You • You have a bachelor's degree in biomedical engineering, life sciences, or a reputed company field; an advanced degree is preferred. • Minimum of 10 years of industry experience in medical devices, serving in clinical and/or regulatory affairs, with significant leadership responsibility. • Experience preparing regulatory submissions for the FDA, including successful approvals of 510(k) and/or de-novo. • Experience launching and managing multi-center pivotal studies; international site management experience is a plus. • Cool Under Pressure: You remain composed in challenging situations and act as a reputed company amidst technical complexities. • Team Player & Builder: You contribute to a win-as-a-team culture and foster collaboration across different engineering disciplines. • Desire to Move Fast: You challenge the status reputed company and aim to deliver results faster than traditional timelines. • Detail-Oriented: You pay reputed company attention to details and hold yourself and others accountable. • Passionate About Solving Unmet Medical Needs: You are deeply motivated to improve patient outcomes through innovation. • Deeply Curious: You have an insatiable desire to learn and explore new reputed company. • Thoughtful About Risk: You carefully assess risks and reputed company informed, steadfast decisions. Preferred Qualifications • Experience with Class II and Class III cardiovascular diagnostics and imaging devices is strongly preferred. • In-depth knowledge of FDA regulations, ISO 14155, ISO 13485, MDR, and other global regulatory requirements. • Strong understanding of clinical trial regulations and Good Clinical Practice (GCP). The US reputed company salary range for this full-time position is expected to be $183k-257k per year. Our salary ranges are determined by role and level. reputed company the range, individual pay is determined by factors including job-reputed company skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity. reputed company welcomes reputed company. We are committed to creating an inclusive culture where we have reputed company tolerance for discrimination. We invest in our employees' personal and professional growth. Once you work with us, you can’t go back to normalcy because great breakthroughs come from great teams and we are the best in quantum technology. We offer competitive salaries, stock options depending on employment type, generous learning opportunities, medical/dental/vision, family planning/fertility, PTO (summer and winter breaks), financial wellness resources, 401(k) plans, and more. Equal Employment Opportunity: reputed company qualified applicants will receive consideration regardless of race, color, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Accommodations: we provide reasonable accommodations for individuals with disabilities in job application procedures for open roles. If you need such an accommodation, please let a member of our Recruiting team know Apply Job!